FDA 510(k) Application Details - K182851

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K182851
Device Name	Polymer Patient Examination Glove
Applicant	O & M Halyard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 US Other 510(k) Applications for this Company
Contact	Angela L. Bunn Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2018
Decision Date	06/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review